Common aes associated with giotrif afatinib are generally well managed with supportive care. Gilotrif is indicated for the firstline treatment of patients with metastatic nonsmall cell lung cancer nsclc whose tumors have non resistant epidermal growth factor receptor egfr. Contact lens use is also a risk factor for keratitis and ulceration. Submission is based on a metaanalysis of three luxlung phase iii studies that examined gilotrif afatinib in nsclc patients whose tumors have uncommon egfr mutations.
Take this medicine exactly as your doctor tells you to. Gilotrif has not been studied in patients with severe child pugh c hepatic impairment. Safety and efficacy of gilotrif were not established in patients whose tumors have resistant egfr mutations. Inlyta axitinib tablets 2ndline mrcc treatment safety. A premature discontinuation of pradaxa increases the risk of thrombotic events, and b spinalepidural hematoma see full prescribing information for complete boxed warning procedures when possible, then restart promptly 2. Food and drug administration fda granted approval to afatinib gilotrif for a broadened indication in firstline treatment of patients with metastatic. Gilotrif is indicated for the firstline treatment of patients with metastatic nonsmall cell lung cancer nsclc whose tumors have nonresistant epidermal growth factor receptor egfr mutations as detected by an fdaapproved test see dosage and administration 2. Take gilotrif at least 1 hour before or 2 hours after a meal. Diarrhea is common with gilotrif and may sometimes be severe. Boehringer ingelheim pharmaceuticals, inc january 2018. Severe diarrhea can cause loss of body fluid dehydration and kidney problems that can sometimes lead to death.
Gilotrif is a tyrosine kinase inhibitor indicated for the first line treatment of patients with. Highlights of prescribing information tafinlar with. Highlights of prescribing information interstitial lung. During your treatment with gilotrif, your doctor should prescribe medicines to treat diarrhea. Fda approves afatinib for previously untreated, metastatic nsclc. Refer to the trametinib prescribing information for recommended trametinib dosing information.
Gilotrif is also indicated for the treatment of patients with metastatic squamous. Therefore, treatment of children or adolescents with this medicinal product is not recommended. Tell your healthcare provider about all the medicines you take, including prescription and overthecounter medicines, vitamins, and herbal supplements. Highlights of prescribing information these highlights do not. If you have difficulty viewing the document below, please click here to view the full prescribing information, including the boxed warning. Gilotrif tablets for oral administration are available in 40 mg, 30 mg, or 20 mg of afatinib equivalent to 59. Food and drug administration fda has approved a supplemental new drug application snda for gilotrif afatinib for the firstline treatment of patients with metastatic nonsmall cell lung cancer nsclc whose tumors have nonresistant epidermal growth factor receptor egfr mutations as detected. Please see important safety information and prescribing information in this website. Gilotrif is indicated for the firstline treatment of patients with metastatic nonsmall cell lung cancer nsclc whose tumors have epidermal growth factor receptor egfr exon 19 deletions or exon 21 l858r substitution mutations as detected by an fdaapproved test. Talk to your healthcare provider if this is a concern for you. Coadministration of chronic pgp inducers orally can decrease afatinib exposure. Gilotrif can cause severe diarrhea, which can be lifethreatening if it leads to.
Patient and caregiver information gilotrif afatinib. Fda approves new indication for gilotrif boehringer ingelheim. Page 1 of 1 12015 gilotrif afatinib overrides approval duration prior authorization quantity limit 1 year medications quantity limit. Metastatic lung adenocarcinoma with nonresistant egfr. Established safety profile based on 4,200 patients in clinical trials 1. Arterial occlusion has occurred in at least 35% of iclusig treated patients including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain. Do not take this medicine in larger or smaller amounts or for longer than recommended. Your healthcare provider will perform a test to make sure that gilotrif is right for you. Oct 01, 2019 other clinically important adverse reactions observed in patients treated with gilotrif but that occurred at a higher incidence in pemetrexedcisplatintreated patients and not listed elsewhere in section 6 include. Tarceva is not recommended for use in combination with platinumbased chemotherapy see clinical studies 14. Highlights of prescribing information recommended dosage in. Patient and caregiver information gilotrif afatinib tablets.
Highlights of prescribing information these highlights do. Gilotrif is a prescription medicine that is used to treat people with nonsmall cell lung cancer nsclc that. Initiate treatment with letairis in females of reproductive potential only after a negative pregnancy test. Afatinib gilotrif national drug monograph october 2015.
Are there specific drug issues with afatinib that are best managed by the non formulary. One filmcoated tablet contains 40 mg afatinib as dimaleate. Inlyta may cause fertility problems in males and females, which may affect your ability to have a child. Pradaxa dabigatran etexilate mesylate capsules, for oral use. See package insert for patient counseling information and medication guide. Truvada emtricitabine and tenofovir disoproxil fumarate tablets, for oral use initial u. Gilotrif afatinib is kinase inhibitor indicated for the firstline treatment of patients with metastatic nonsmall cell lung cancer nsclc whose tumors have nonresistant epidermal growth factor receptor egfr mutations as detected by an fdaapproved. Posttreatment acute exacerbation of hepatitis b and risk of drug resistance with use of truvada for hiv1 preexposure prophylaxis prep in. Closely monitor patients with severe hepatic impairment and adjust gilotrif dose if not tolerated. These highlights do not include all the information needed to use. Giotrif afatinib is an irreversible erbb inhibitor approved in nonsmallcell lung cancer. Egfr testing is done prior to starting to see if the lung cancer cells have the specific mutation in egfr that predicts a positive response to afatinib. Afatinib is an anilinequinazoline derivative that is a highly selective, potent, and irreversible inhibitor of both epidermal growth factor receptor egfr and human epidermal growth factor receptor her2 kinases.
Similar safety and efficacy of once and twicedaily lopinavirritonavir tablets in treatment experienced hiv1infected subjects at 48 weeks. Take gilotrif on an empty stomach, at least 1 hour before or 2 hours after a meal. Arterial occlusion has occurred in at least 35% of iclusig treated patients including fatal myocardial infarction. Deplin is the only product with 15 mg of metafolin lmethylfolate calcium, which is clinically proven and has been widely studied in over 25 clinical trials as registered on clinicaltrials. Oct 18, 2019 gilotrif is a kinase inhibitor indicated for. Deplin is the most prescribed product in its class. Gilotrif can cause fetal harm when administered to a pregnant woman. Gilotrif afatinib prior auth criteria proprietary information.
Withhold gilotrif for any drugrelated adverse reactions of. The recommended dose of gilotrif is 40 mg orally once daily until disease progression or no longer tolerated by the patient. Based on its mechanism of action, gilotrif can cause fetal harm when administered to a pregnant woman. Gilotrif afatinib rationale for inclusion in pa program. Highlights of prescribing information these highlights do not include all the information needed to use gilotrif safely and effectively. May 04, 2020 gilotrif is usually taken once per day. Gilotrif fda prescribing information, side effects and uses. Gilotrif afatinib tablets is indicated for the firstline treatment of patients with metastatic nonsmall cell lung cancer nsclc whose tumors have nonresistant epidermal growth factor receptor egfr mutations as detected by an fdaapproved test. Renal impairment as a consequence of diarrhea occurred in 7% of patients treated with gilotrif, of which 2% were grade 3 see adverse reactions 6. Read the patient information leaflet if available from your pharmacist before you start taking afatinib and each time you get a refill. Gilotrif is indicated for the firstline treatment of patients with metastatic nonsmall cell lung cancer nsclc whose tumors have nonresistant epidermal growth factor receptor egfr mutations as detected by. See full prescribing information for complete boxed warning.
Safety and effectiveness of gilotrif in pediatric patients have not been established1. Firstline treatment of patients with metastatic nonsmall cell lung cancer nsclc whose tumors have nonresistant epidermal growth factor receptor egfr mutations as detected by an fdaapproved test limitations of use. Gilotrif is indicated for the firstline treatment of patients with metastatic nonsmall cell lung cancer nsclc whose tumors have nonresistant epidermal growth factor receptor egfr mutations as. Vizimpro dacomitinib is a prescription medicine used to treat nonsmall cell lung cancer nsclc that has spread to other parts of the body metastatic vizimpro is used as a first treatment if your tumor has certain types of abnormal epidermal growth factor receptor egfr genes. Gilotrif boehringer ingelheim pharmaceuticals, inc. Antiretroviral medication kaletra lopinavirritonavir. Do not take a missed dose within 12 hours of the next dose. Highlights of prescribing information these highlights do not include all the information needed to use hydrea safely and effectively. Afatinib dimaleate is a white to brownish yellow powder, water soluble and hygroscopic, with an empirical formula of c32h33clfn5o11, and a molecular weight of 718.
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